Controlling mAb Aggregates In Chromatography Process Development

Monoclonal antibodies and antibody variants underpin much of today’s biotherapeutic development, yet achieving therapeutic-grade purity remains a complex challenge. Even with optimized cell culture conditions, downstream purification must contend with a range of impurities, including host cell proteins, charged variants, and product-related species such as aggregates. Aggregation is particularly concerning, as it can occur throughout processing and is often exacerbated in fragments and bispecific antibodies. These species not only compromise product efficacy but also raise immunogenicity and regulatory risks. Because aggregates closely resemble monomeric antibodies in their physicochemical properties, effective separation is far from trivial. Addressing aggregation, therefore, requires deliberate process design and carefully selected purification strategies. Drawing on experimental studies, downstream chromatographic approaches are presented that have proven effective in reducing aggregate levels and improving overall product quality.

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